Medical affairs Jobs in Lowell, MA

Vice President / Global Head, Regulatory Affairs

Join to apply for the Vice President / Global Head, Regulatory Affairs role at Cardurion Pharmaceuticals .

This role is either Hybrid in Burlington, MA or Remote.

Why join Cardurion Pharma?

We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing towards our goal of building a world-class biotechnology company that discovers, develops and commercializes life-changing therapeutics for patients with cardiovascular disease.

The Role

The VP, Global Head of Regulatory Affairs will be a key member of the R&D leadership team, responsible for leading the global regulatory organization. They will oversee and be accountable for the following functions : Regulatory Strategy, CMC Regulatory Affairs, and Regulatory Operations.

Here’s What You’ll Do :

• A key member of the R&D leadership team, responsible for overseeing leadership of the global regulatory organization.
• Oversee and be accountable for growing and leading a regulatory organization inclusive of the following functions : Regulatory Strategy, CMC Regulatory Affairs, and Regulatory Operations.
• Works with program team members to establish regulatory strategies for development programs and provides insight and direction to the Business Development function.
• Proactively identifies potential strategic issues / opportunities and communicates potential risks associated with strategic scenarios.
• Oversees and / or leads both clinical and CMC related regulatory agency interactions.
• Monitors US, EU and Global regulations, and assesses any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
• Develops strategies for complex issues with potential for significant regulatory compliance impact.
• Builds mutually respectful and collaborative working relationships with other key functions and motivates the group to the highest level of performance and quality.
• Able to hold people accountable, provide thoughtful and accurate feedback; delegate appropriately, drive to develop and retain top talent.
• Builds relationships and leads a cross-functional team through influence.
• Adapts quickly to changing conditions and is a calming leader to their group in times of uncertainty.
• Serves as the single point of contact for all regulatory interactions and remains current on all active programs.
• Establishes clear responsibilities and processes for monitoring work and measuring results.
• Actively seeks input from pertinent sources to make timely and well-informed decisions.

Here’s What We’ll Bring To The Table :

Our Mission

Translate our world-class expertise in cardiovascular signaling pathways into potentially groundbreaking therapeutics for patients.

Requirements :

Seniority level

Executive

Employment type

Full-time

Job function

Legal

Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants.

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